Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer

  • STATUS
    Recruiting
  • End date
    Aug 1, 2027
  • participants needed
    1650
  • sponsor
    Fudan University
Updated on 1 November 2021
endocrine therapy
hormone therapy
advanced breast cancer
HER2
erbb2
herceptin
locally advanced breast cancer
invasive breast cancer
taxane
mastectomy
adjuvant chemotherapy
breast reconstruction

Summary

Locally advanced breast cancer has high-risk local regional recurrence after surgery. Radiotherapy could reduce the local regional recurrence and improve disease free survival and overall survival. Regional lymph node irradiation is the important part of breast cancer radiotherapy. However, there are some controversies about regional lymph node delineation, especially the supraclavicular irradiation volume. Many studies had confirmed that posterolateral region of the supraclavicular fossa (also named Posterior neck lymph node) had a high risk involvement based on the mapping of recurrence nodes. This randomized phase III trial compares medial supraclavicular lymph node irradiation with entire supraclavicular lymph node irradiation in patients with pathologically positive axillary lymph node and high risk of recurrence after mastectomy or breast conservative surgery. It is not yet known if radiation works better with entire supraclavicular fossa than medial supraclavicular fossa.

Description

PRIMARY OBJIECTIVE:

I. To evaluate whether entire supraclavicular lymph node irradiation is superior to medial supraclavicular lymph node irradiation in terms of disease free survival for patients with positive lymph nodes and high risk of recurrence after breast cancer surgery

SECONDARY OBJECTIVES:

I. To estimate the difference of overall survival II. to estimate the difference of ipsilateral supraclavicular node recurrence III. to estimate the difference of local regional recurrence IV. to estimate the difference of radiation related toxicities and quality of life.

Outline: Beginning 2-12 weeks after the completion of breast cancer surgery and neoadjuvant/adjuvant chemotherapy, patients are randomized to 1 of 2 treatment arms Arm I: Patients undergo breast/chest wall, undissected axillary, internal mammary node and medial supraclavicular node radiation. Conventional fractionated radiotherapy 50Gy/25Fx/5w or hypofractionated 42.5Gy/16Fx/3.5week with IMRT or VAMT technique is recommended. 3DCRT technique is not permitted.

Arm II: Patients undergo breast/chest wall, undissected axillary, internal mammary node and entire supraclavicular node radiation. Conventional fractionated radiotherapy 50Gy/25Fx/5w or hypofractionated 42.5Gy/16Fx/3.5week with IMRT or VAMT technique is recommended. 3DCRT technique is not permitted

Details
Condition Breast Cancer Diagnosis, cancer, breast, Effects of Radiation Therapy, breast carcinoma, Radiotherapy; Complications, Breast Cancer
Treatment Entire supraclavicular lymph node radiotherapy, Medial supraclavicular lymph node radiotherapy
Clinical Study IdentifierNCT05059379
SponsorFudan University
Last Modified on1 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

ECOG 0-1
Newly diagnosed invasive breast cancer
Initial clincial diagonosis stage is T1-4, N0-3a/b, M0: If neoadjuvant chemotherapy was not administered: pathological stage is T1-3N2-3a/b, M0; If neoadjuvant chemotherapy was administeredclinical stage III or pathological stage is T1-4N1-3a/bM0
Underwent breast conservative surgery or Mastectomy with or without breast reconstruction with clear negative margin. At least, axillary level I and level II should be cleared with 10 lymph node (including the number of sentinal lymph node) . Level III dissection and internal mamamry node dissection are not required, but may be performed at the discretion of the surgeon
Should receive 6 cycles standard neoadjuvant and/or adjuvant chemotherapy (taxane and/or anthracycline based)
Enrolled on the trial within 12 weeks of the later of two dates: the final breast cancer surgical procedure or administration of the last cycle of cytotoxic chemotherapy
For ER and/or PR positive patients, the duration of anticipated endocrine therapy should be5 year ; For HER2 postive patients, the duration of anticipated herceptin should be 1 year
Writtern, informed consent

Exclusion Criteria

Initinal clinical diagnosis N3c (supraclavicualr node metastasis)
T4 or inflamed breast cancer with no good downstage by neoadjuvant chemotherapy
Distant metastasis
Bilateral breast cancer or previously contralateral breast cancer
Positve sentinal lymph node with no axillary dissection
ECOG 2
Could not tolerate chemotherapy and anti-HER2 target treatment
Active infectious
History of radiotherapy
Serious medical complcation
Breast cancer during pregnancy and lactation
Had simultaneousl or previous secondary malignancies, except for skin basal cell carcinoma and cervical carcinoma in situ
Inaccessibility for follow-up
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